FDA advisory committee recommends approval of Novartis’ MS drug
06-11-2010
An advisory committee of the US Food and Drug Administration (FDA) recommended approval of FTY720 (fingolimod) for the treatment of patients with relapsing multiple sclerosis, according to the company. The committee voted unanimously that FTY720 demonstrated substantial efficacy in treating relapsing remitting MS and that safety of the proposed 0.5 mg dose justified approval.
The committee evaluated data from the largest clinical trial program ever submitted to the FDA as part of an MS new drug application. This study data provided evidence of superior efficacy of FTY720 over one of the most commonly prescribed treatments, interferon beta-1a IM (Avonex®), and to placebo, in reducing relapses and brain lesions (a measure of disease activity). In addition, the two-year placebo-controlled study showed FTY720 significantly delayed disability progression. The advisory committee discussed monitoring parameters for the therapeutic use of FTY720 and also recommended post-marketing collection of additional safety data and evaluation of a lower dose.
If approved, FTY720 would potentially be the first oral therapy for treating relapsing MS.
The FDA granted FTY720 priority review status in February 2010, reducing the standard 10-month review to six months. In May, the FDA extended the priority review period by three months to September 2010.
Avonex® is a registered trademark of Biogen Idec.
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